semaglutide
22 May 2024
There are various approved formulations of semaglutide, to be administered orally or subcutaneously.
Subcutaneous semaglutide
Subcutaneous semaglutide, a once-weekly peptide-based GLP-1 RA, is highly effective in achieving and maintaining glycaemic targets in people with T2DM. It also promotes weight loss in adults with overweight or obesity and reduces the risk of major adverse cardiovascular events in this population . Additionally, semaglutide has been shown to significantly reduce the risk of kidney disease progression in adults with T2DM and chronic kidney disease. A label extension for risk reduction of chronic kidney disease (CKD) related events has been filed based on these findings, with a regulatory decision expected in the first half of 2025. Additional regulatory submissions are anticipated in 2025, following successful phase III trials investigating semaglutide’s potential to reduce heart failure outcomes and improve metabolic dysfunction-associated steatohepatitis (MASH). To date, semaglutide remains the GLP-1 RA with the most advanced clinical profile. Primary patents on semaglutide expiring between 2024-2026 have been or granted in few LMICs. Patents on the sub-cutaneous formulation expired in 2024. Novo Nordisk owns many secondary patents that may extend exclusivity until 2040.
Oral semaglutide
Oral semaglutide, a once daily peptide-based GLP-1 RA, is highly effective in achieving and maintaining glycaemic targets while also promoting weight loss in people with T2DM. Clinical trials have demonstrated additional benefits, including a reduction in major adverse cardiovascular events (MACE) in those with T2DM and either cardiovascular disease or chronic kidney disease. A label extension was submitted to the FDA for the prevention of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD) at the end of 2024. A higher-dose formulation of oral semaglutide has also been shown to support weight management in adults with obesity or overweight. As a result, regulatory filing for an obesity indication may take place in 2025, which would make it the first oral GLP-1 therapy approved for this use. The oral formulation of semaglutide may make it appropriate for use in resource limited settings as it is heat stable. Primary patents on semaglutide expiring between 2024-2026 have been or granted in few LMICs. Secondary patents on semaglutide solid compositions with salcaprozate sodium, an important excipient of the finished product, have been filed in about seventeen LMICs, including major manufacturing countries such as India, South Africa, China and Brazil where they are expected to expire in 2031. Novo Nordisk owns many secondary patents that may extend exclusivity until 2040.